Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-02-22 @ 3:55 PM
Study NCT ID:
NCT03901534
Status:
TERMINATED
Last Update Posted:
2024-12-20
First Post:
2019-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessment of Continuous Positive Airway Pressure Therapy in OSA and ILD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sj366@cumc.columbia.edu', 'phone': '212-543-8875', 'title': 'Sanja Jelic, MD', 'organization': 'Columbia University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 24 weeks', 'description': 'Adverse events were not collected from the Aim 3b cohort due to early study termination.', 'eventGroups': [{'id': 'EG000', 'title': 'Aim 1 Cohort: MESA', 'description': 'This cohort includes biospecimens collected from 1852 participants in the MESA sleep study \\[Chen et al\\]. Serum biomarkers were measured by immunoassay in the Laboratory for Clinical Biochemistry Research at the University of Vermont.', 'otherNumAtRisk': 1852, 'deathsNumAtRisk': 1852, 'otherNumAffected': 0, 'seriousNumAtRisk': 1852, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Aim 2 Cohort: HeartBEAT and BestAir', 'description': 'This cohort includes 62 men and 20 women with newly diagnosed moderate-to-severe OSA and without known severe lung disease, who had participated in either of two randomized trials of PAP therapy, the HeartBEAT \\[Gottlieb et al\\] and BestAIR \\[Bakker et al\\] studies. Participants were selected for this analysis based on mean PAP adherence of =4 hours daily over a follow-up period of 3 months in the HeartBEAT study and 6 months in the BestAIR study.\n\nMorning serum samples drawn at baseline and at the end of the PAP treatment period were assayed using commercially available ELISA for each biomarker in the Laboratory for Clinical Biochemistry Research at the University of Vermont Larner College of Medicine.', 'otherNumAtRisk': 82, 'deathsNumAtRisk': 82, 'otherNumAffected': 0, 'seriousNumAtRisk': 82, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Aim 3a Cohort: CPAP Treatment of OSA', 'description': 'Participants with OSA will be treated with CPAP.', 'otherNumAtRisk': 87, 'deathsNumAtRisk': 87, 'otherNumAffected': 0, 'seriousNumAtRisk': 87, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Aim 3b Cohort: ILD Screening for OSA', 'description': 'Participants with ILD will be screened for OSA by polysomnography.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Surfactant Protein D (SP-D) [Aim 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1852', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MESA', 'description': 'This cohort includes biospecimens collected from 1852 participants in the MESA sleep study \\[Chen et al\\]. Serum biomarkers were measured by immunoassay in the Laboratory for Clinical Biochemistry Research at the University of Vermont.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'spread': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'SP-D is a marker of alveolar epithelial cell injury.\n\nThis Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'E-selectin [Aim 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1852', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MESA', 'description': 'This cohort includes biospecimens collected from 1852 participants in the MESA sleep study \\[Chen et al\\]. Serum biomarkers were measured by immunoassay in the Laboratory for Clinical Biochemistry Research at the University of Vermont.'}], 'classes': [{'categories': [{'measurements': [{'value': '20438', 'spread': '10558', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'This Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Angiopoietin-2 [Aim 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1852', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MESA', 'description': 'This cohort includes biospecimens collected from 1852 participants in the MESA sleep study \\[Chen et al\\]. Serum biomarkers were measured by immunoassay in the Laboratory for Clinical Biochemistry Research at the University of Vermont.'}], 'classes': [{'categories': [{'measurements': [{'value': '1785', 'spread': '1082', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'This Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Vascular Endothelial Growth Factor-A (VEGF-A) [Aim 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1852', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MESA', 'description': 'This cohort includes biospecimens collected from 1852 participants in the MESA sleep study \\[Chen et al\\]. Serum biomarkers were measured by immunoassay in the Laboratory for Clinical Biochemistry Research at the University of Vermont.'}], 'classes': [{'categories': [{'measurements': [{'value': '156', 'spread': '125', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'This Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Angiopoietin-interacting Soluble Tie-2 (sTie2) [Aim 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1852', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MESA', 'description': 'This cohort includes biospecimens collected from 1852 participants in the MESA sleep study \\[Chen et al\\]. Serum biomarkers were measured by immunoassay in the Laboratory for Clinical Biochemistry Research at the University of Vermont.'}], 'classes': [{'categories': [{'measurements': [{'value': '83496', 'spread': '15417', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'This Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Serum Matrix Metalloproteinase-7 (MMP-7) Following CPAP [Aim 2]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HeartBEAT and BestAir', 'description': 'This cohort includes 62 men and 20 women with newly diagnosed moderate-to-severe OSA and without known severe lung disease, who had participated in either of two randomized trials of PAP therapy, the HeartBEAT \\[Gottlieb et al\\] and BestAIR \\[Bakker et al\\] studies. Participants were selected for this analysis based on mean PAP adherence of ≥4 hours daily over a follow-up period of 3 months in the HeartBEAT study and 6 months in the BestAIR study.\n\nMorning serum samples drawn at baseline and at the end of the PAP treatment period were assayed using commercially available ELISA for each biomarker in the Laboratory for Clinical Biochemistry Research at the University of Vermont Larner College of Medicine.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.004', 'groupId': 'OG000', 'lowerLimit': '-0.25', 'upperLimit': '0.26'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and post-CPAP follow-up, up to 24 Weeks', 'description': 'The differences between-arms in the longitudinal changes of MMP-7 will be measured. For the purpose of this analysis, all individuals receiving active CPAP in the experimental arm will be compared to all individuals receiving sham CPAP device in the control arm.\n\nThis Outcome is specific to Aim 2 and will only be measured on participants in the Aim 2 phase of the study.', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Serum Surfactant Protein-D (SP-D) Following CPAP [Aim 2]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HeartBEAT and BestAir', 'description': 'This cohort includes 62 men and 20 women with newly diagnosed moderate-to-severe OSA and without known severe lung disease, who had participated in either of two randomized trials of PAP therapy, the HeartBEAT \\[Gottlieb et al\\] and BestAIR \\[Bakker et al\\] studies. Participants were selected for this analysis based on mean PAP adherence of ≥4 hours daily over a follow-up period of 3 months in the HeartBEAT study and 6 months in the BestAIR study.\n\nMorning serum samples drawn at baseline and at the end of the PAP treatment period were assayed using commercially available ELISA for each biomarker in the Laboratory for Clinical Biochemistry Research at the University of Vermont Larner College of Medicine.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.68', 'groupId': 'OG000', 'lowerLimit': '-0.18', 'upperLimit': '1.53'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and post-CPAP follow-up, up to 24 Weeks', 'description': 'The between-arm difference in the longitudinal changes of SP-D will be measured. For the purpose of this analysis, all individuals receiving active CPAP in the experimental arm will be compared to all individuals receiving sham CPAP device in the control arm.\n\nThis Outcome is specific to Aim 2 and will only be measured on participants in the Aim 2 phase of the study.', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Serum Angiopoietin-2 (Ang-2) Following CPAP [Aim 2]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HeartBEAT and BestAir', 'description': 'This cohort includes 62 men and 20 women with newly diagnosed moderate-to-severe OSA and without known severe lung disease, who had participated in either of two randomized trials of PAP therapy, the HeartBEAT \\[Gottlieb et al\\] and BestAIR \\[Bakker et al\\] studies. Participants were selected for this analysis based on mean PAP adherence of ≥4 hours daily over a follow-up period of 3 months in the HeartBEAT study and 6 months in the BestAIR study.\n\nMorning serum samples drawn at baseline and at the end of the PAP treatment period were assayed using commercially available ELISA for each biomarker in the Laboratory for Clinical Biochemistry Research at the University of Vermont Larner College of Medicine.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.28', 'groupId': 'OG000', 'lowerLimit': '0.08', 'upperLimit': '0.48'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and post-CPAP follow-up, up to 24 Weeks', 'description': 'The between-arm difference in the longitudinal changes of Ang-2 will be measured. For the purpose of this analysis, all individuals receiving active CPAP in the experimental arm will be compared to all individuals receiving sham CPAP device in the control arm.\n\nThis Outcome is specific to Aim 2 and will only be measured on participants in the Aim 2 phase of the study.', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Serum Osteopontin Following CPAP [Aim 2]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HeartBEAT and BestAir', 'description': 'This cohort includes 62 men and 20 women with newly diagnosed moderate-to-severe OSA and without known severe lung disease, who had participated in either of two randomized trials of PAP therapy, the HeartBEAT \\[Gottlieb et al\\] and BestAIR \\[Bakker et al\\] studies. Participants were selected for this analysis based on mean PAP adherence of ≥4 hours daily over a follow-up period of 3 months in the HeartBEAT study and 6 months in the BestAIR study.\n\nMorning serum samples drawn at baseline and at the end of the PAP treatment period were assayed using commercially available ELISA for each biomarker in the Laboratory for Clinical Biochemistry Research at the University of Vermont Larner College of Medicine.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.80', 'groupId': 'OG000', 'lowerLimit': '-5.97', 'upperLimit': '4.36'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and post-CPAP follow-up, up to 24 Weeks', 'description': 'The differences between-arms in the longitudinal changes of Osteopontin will be measured. For the purpose of this analysis, all individuals receiving active CPAP in the experimental arm will be compared to all individuals receiving sham CPAP device in the control arm.\n\nThis Outcome is specific to Aim 2 and will only be measured on participants in the Aim 2 phase of the study.', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Serum Angiopoietin-2 (Ang-2, ng/mL) [Aim 3a]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CPAP Treatment of OSA', 'description': 'Participants with OSA will be treated with CPAP.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1889', 'spread': '903', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '2153', 'spread': '926', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Participants will be treated with CPAP for 4 weeks. Serum Ang-2 levels will be measured at baseline and after CPAP therapy.\n\nThis Outcome is specific to Aim 3a and will only be measured on participants in the Aim 3a phase of the study.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Serum Surfactant Protein-A (SP-A, ng/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MESA', 'description': 'This cohort includes biospecimens collected from 1852 participants in the MESA sleep study \\[Chen et al\\]. Serum biomarkers were measured by immunoassay in the Laboratory for Clinical Biochemistry Research at the University of Vermont.'}], 'timeFrame': 'Up to 24 weeks', 'description': 'The between-arm difference in the longitudinal changes of SP-A will be measured.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected thus cannot be analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Community Based Multi-Ethnic Study of Atherosclerosis (MESA)', 'description': 'This cohort includes biospecimens collected from 1852 participants in the MESA sleep study \\[Chen et al\\]. Serum biomarkers were measured by immunoassay in the Laboratory for Clinical Biochemistry Research at the University of Vermont.'}, {'id': 'FG001', 'title': 'HeartBEAT and BestAir', 'description': 'This cohort includes 62 men and 20 women with newly diagnosed moderate-to-severe OSA and without known severe lung disease, who had participated in either of two randomized trials of PAP therapy, the HeartBEAT \\[Gottlieb et al\\] and BestAIR \\[Bakker et al\\] studies. Participants were selected for this analysis based on mean PAP adherence of =4 hours daily over a follow-up period of 3 months in the HeartBEAT study and 6 months in the BestAIR study.\n\nMorning serum samples drawn at baseline and at the end of the PAP treatment period were assayed using commercially available ELISA for each biomarker in the Laboratory for Clinical Biochemistry Research at the University of Vermont Larner College of Medicine.'}, {'id': 'FG002', 'title': 'CPAP Treatment of OSA', 'description': 'Participants with obstructive sleep apnea (OSA) will be treated with continuous positive airway pressure therapy (CPAP).'}, {'id': 'FG003', 'title': 'ILD Screening for OSA', 'description': 'Participants with interstitial lung disease (ILD) will be screened for OSA by polysomnography.'}], 'periods': [{'title': 'Aim 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1852'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1852'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Aim 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '82'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '82'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Aim 3a', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '87'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '87'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Aim 3b', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment for Aim 3b of the study was terminated before any prospective participants could be enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1852', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2021', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Aim 1 Cohort: MESA', 'description': 'This cohort includes biospecimens collected from 1852 participants in the MESA sleep study \\[Chen et al\\]. Serum biomarkers were measured by immunoassay in the Laboratory for Clinical Biochemistry Research at the University of Vermont.'}, {'id': 'BG001', 'title': 'Aim 2 Cohort: HeartBEAT and BestAir', 'description': 'This cohort includes 62 men and 20 women with newly diagnosed moderate-to-severe OSA and without known severe lung disease, who had participated in either of two randomized trials of PAP therapy, the HeartBEAT \\[Gottlieb et al\\] and BestAIR \\[Bakker et al\\] studies. Participants were selected for this analysis based on mean PAP adherence of =4 hours daily over a follow-up period of 3 months in the HeartBEAT study and 6 months in the BestAIR study.\n\nMorning serum samples drawn at baseline and at the end of the PAP treatment period were assayed using commercially available ELISA for each biomarker in the Laboratory for Clinical Biochemistry Research at the University of Vermont Larner College of Medicine.'}, {'id': 'BG002', 'title': 'Aim 3a Cohort: CPAP Treatment of OSA', 'description': 'Participants with OSA will be treated with CPAP.'}, {'id': 'BG003', 'title': 'Aim 3b Cohort: ILD Screening for OSA', 'description': 'Participants with ILD will be screened for OSA by polysomnography.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1852', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2021', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '68', 'spread': '9', 'groupId': 'BG000'}, {'value': '65', 'spread': '7', 'groupId': 'BG001'}, {'value': '46', 'spread': '13', 'groupId': 'BG002'}, {'value': '60', 'spread': '10', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1852', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2021', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '979', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '1040', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '873', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '981', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1852', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2021', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '1852', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}, {'value': '2021', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'No participants were enrolled for Aim 3b.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-06-03', 'size': 287830, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-11-14T13:01', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'None (Open Label)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2021}}, 'statusModule': {'whyStopped': 'Enrollment challenges', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-13', 'studyFirstSubmitDate': '2019-04-02', 'resultsFirstSubmitDate': '2024-11-14', 'studyFirstSubmitQcDate': '2019-04-02', 'lastUpdatePostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-13', 'studyFirstPostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Serum Surfactant Protein-A (SP-A, ng/mL)', 'timeFrame': 'Up to 24 weeks', 'description': 'The between-arm difference in the longitudinal changes of SP-A will be measured.'}], 'primaryOutcomes': [{'measure': 'Surfactant Protein D (SP-D) [Aim 1]', 'timeFrame': '1 day', 'description': 'SP-D is a marker of alveolar epithelial cell injury.\n\nThis Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.'}, {'measure': 'E-selectin [Aim 1]', 'timeFrame': '1 day', 'description': 'This Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.'}, {'measure': 'Angiopoietin-2 [Aim 1]', 'timeFrame': '1 day', 'description': 'This Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.'}, {'measure': 'Vascular Endothelial Growth Factor-A (VEGF-A) [Aim 1]', 'timeFrame': '1 day', 'description': 'This Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.'}, {'measure': 'Angiopoietin-interacting Soluble Tie-2 (sTie2) [Aim 1]', 'timeFrame': '1 day', 'description': 'This Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.'}, {'measure': 'Change in Serum Matrix Metalloproteinase-7 (MMP-7) Following CPAP [Aim 2]', 'timeFrame': 'Baseline and post-CPAP follow-up, up to 24 Weeks', 'description': 'The differences between-arms in the longitudinal changes of MMP-7 will be measured. For the purpose of this analysis, all individuals receiving active CPAP in the experimental arm will be compared to all individuals receiving sham CPAP device in the control arm.\n\nThis Outcome is specific to Aim 2 and will only be measured on participants in the Aim 2 phase of the study.'}, {'measure': 'Change in Serum Surfactant Protein-D (SP-D) Following CPAP [Aim 2]', 'timeFrame': 'Baseline and post-CPAP follow-up, up to 24 Weeks', 'description': 'The between-arm difference in the longitudinal changes of SP-D will be measured. For the purpose of this analysis, all individuals receiving active CPAP in the experimental arm will be compared to all individuals receiving sham CPAP device in the control arm.\n\nThis Outcome is specific to Aim 2 and will only be measured on participants in the Aim 2 phase of the study.'}, {'measure': 'Change in Serum Angiopoietin-2 (Ang-2) Following CPAP [Aim 2]', 'timeFrame': 'Baseline and post-CPAP follow-up, up to 24 Weeks', 'description': 'The between-arm difference in the longitudinal changes of Ang-2 will be measured. For the purpose of this analysis, all individuals receiving active CPAP in the experimental arm will be compared to all individuals receiving sham CPAP device in the control arm.\n\nThis Outcome is specific to Aim 2 and will only be measured on participants in the Aim 2 phase of the study.'}, {'measure': 'Change in Serum Osteopontin Following CPAP [Aim 2]', 'timeFrame': 'Baseline and post-CPAP follow-up, up to 24 Weeks', 'description': 'The differences between-arms in the longitudinal changes of Osteopontin will be measured. For the purpose of this analysis, all individuals receiving active CPAP in the experimental arm will be compared to all individuals receiving sham CPAP device in the control arm.\n\nThis Outcome is specific to Aim 2 and will only be measured on participants in the Aim 2 phase of the study.'}, {'measure': 'Serum Angiopoietin-2 (Ang-2, ng/mL) [Aim 3a]', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Participants will be treated with CPAP for 4 weeks. Serum Ang-2 levels will be measured at baseline and after CPAP therapy.\n\nThis Outcome is specific to Aim 3a and will only be measured on participants in the Aim 3a phase of the study.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Interstitial Lung Disease (ILD)', 'Obstructive Sleep Apnea (OSA)', 'CPAP'], 'conditions': ['Interstitial Lung Disease', 'Obstructive Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '25409106', 'type': 'BACKGROUND', 'citation': 'Chen X, Wang R, Zee P, Lutsey PL, Javaheri S, Alcantara C, Jackson CL, Williams MA, Redline S. Racial/Ethnic Differences in Sleep Disturbances: The Multi-Ethnic Study of Atherosclerosis (MESA). Sleep. 2015 Jun 1;38(6):877-88. doi: 10.5665/sleep.4732.'}, {'pmid': '24918372', 'type': 'BACKGROUND', 'citation': 'Gottlieb DJ, Punjabi NM, Mehra R, Patel SR, Quan SF, Babineau DC, Tracy RP, Rueschman M, Blumenthal RS, Lewis EF, Bhatt DL, Redline S. CPAP versus oxygen in obstructive sleep apnea. N Engl J Med. 2014 Jun 12;370(24):2276-85. doi: 10.1056/NEJMoa1306766.'}, {'pmid': '27018174', 'type': 'BACKGROUND', 'citation': 'Bakker JP, Wang R, Weng J, Aloia MS, Toth C, Morrical MG, Gleason KJ, Rueschman M, Dorsey C, Patel SR, Ware JH, Mittleman MA, Redline S. Motivational Enhancement for Increasing Adherence to CPAP: A Randomized Controlled Trial. Chest. 2016 Aug;150(2):337-45. doi: 10.1016/j.chest.2016.03.019. Epub 2016 Mar 24.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether biomarkers of lung epithelial and endothelial injury are associated with obstructive sleep apnea (OSA) and interstitial lung disease (ILD).', 'detailedDescription': 'This study is comprised of 3 aims:\n\nAim 1: Determine whether the greater OSA severity is associated with higher levels of serum biomarkers of AEC and endothelial injury and ECM remodeling in community-dwelling adults. This is a retrospective study that will analyze biospecimens from those who participated in the MESA sleep study \\[Chen et al\\].\n\nAim 2: Determine whether CPAP use is associated with reductions in alveolar epithelial cell (AEC) injury and endothelial injury, and extracellular matrix (ECM) remodeling biomarkers in adults with moderate-to-severe OSA. This is a retrospective study that will analyze biospecimens from those who participated in either the HeartBEAT \\[Gottlieb et al\\] and BestAIR \\[Bakker et al\\] studies.\n\nRevised Aim 3: a) Determine whether untreated OSA promotes AEC and endothelial injury and ECM remodeling biomarkers in adults with ILD and OSA compared with those without OSA; b) Determine prospectively whether clinically-initiated 4-week PAP therapy increases markers of alveolar endothelial lung injury in OSA. Participants will be recruited at Columbia University and be assigned CPAP therapy as an intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for Patients with ILD:\n\n1. Ability to provide informed consent.\n2. Age 18 years or greater\n3. Diagnosis of any of the following fibrotic interstitial lung diseases as defined by ATS/ERS/JRS/ALAT guidelines and research statements and Delphi surveys:\n\n * Idiopathic pulmonary fibrosis\n * Idiopathic non-specific interstitial pneumonia (NSIP) with fibrosis\n * Chronic hypersensitivity pneumonitis with fibrosis\n * Connective tissue disease related interstitial lung disease (CTD-ILD)\n * Unclassifiable idiopathic interstitial pneumonia with fibrosis\n\nExclusion criteria for Patients with ILD:\n\n1. Clinically significant lung disease other than fibrotic interstitial lung disease\n2. Planned change to the IPF treatment during the study period\n3. Current cigarette smoking (past 4 weeks)\n4. Lower respiratory tract infection in past 60 days. (Upper respiratory tract infection is not a contraindication)\n5. History of life-threatening cardiac arrhythmias\n6. Known chronic heart failure (LVEF \\< 45% or echo evidence of RV dysfunction or PH)\n7. Chronic opiate analgesic use\n8. History of sleepiness-related automobile accident within past year of enrollment\n9. Expected survival time in the opinion of the investigator of less than 6 months\n10. History of stroke or spinal cord injury\n\nInclusion criteria for OSA patients:\n\n1. Age 18 years or greater\n2. Clinical diagnosis of untreated OSA documented by nocturnal polysomnography\n\nExclusion criteria for OSA patients:\n\n1. Current treatment with CPAP or oral appliance\n2. Identical exclusion criteria as for ILD patients'}, 'identificationModule': {'nctId': 'NCT03901534', 'briefTitle': 'Assessment of Continuous Positive Airway Pressure Therapy in OSA and ILD', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Assessment of Continuous Positive Airway Pressure Therapy in OSA and ILD', 'orgStudyIdInfo': {'id': 'AAAR6902'}, 'secondaryIdInfos': [{'id': '1R01HL137234-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01HL137234-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Community based Multi-Ethnic Study of Atherosclerosis (MESA)', 'description': 'This cohort includes biospecimens collected from 1852 participants in the MESA sleep study \\[Chen et al\\]. Serum biomarkers were measured by immunoassay in the Laboratory for Clinical Biochemistry Research at the University of Vermont.\n\nAll participants in this cohort will be analyzed for only the Aim 1 outcome measures.'}, {'type': 'NO_INTERVENTION', 'label': 'HeartBEAT and BestAir', 'description': 'The cohort includes 62 men and 20 women with newly diagnosed moderate-to-severe OSA and without known severe lung disease, who had participated in either of two randomized trials of PAP therapy, the HeartBEAT \\[Gottlieb et al\\] and BestAIR \\[Bakker et al\\] studies. Participants were selected for this analysis based on mean PAP adherence of ≥4 hours daily over a follow-up period of 3 months in the HeartBEAT study and 6 months in the BestAIR study.\n\nMorning serum samples drawn at baseline and at the end of the PAP treatment period were assayed using commercially available ELISA for each biomarker in the Laboratory for Clinical Biochemistry Research at the University of Vermont Larner College of Medicine.\n\nAll participants in this cohort will be analyzed for only the Aim 2 outcome measures.'}, {'type': 'EXPERIMENTAL', 'label': 'CPAP treatment of OSA', 'description': 'Participants with obstructive sleep apnea (OSA) will be treated with continuous positive airway pressure therapy (CPAP).\n\nAll participants in this cohort will be analyzed for only the Aim 3a outcome measures.', 'interventionNames': ['Device: Continuous positive airway pressure (CPAP) therapy']}, {'type': 'EXPERIMENTAL', 'label': 'ILD screening for OSA', 'description': 'Participants with interstitial lung disease (ILD) will be screened for OSA by polysomnography.\n\nAll participants in this cohort will be analyzed for only the Aim 3b outcome measures.', 'interventionNames': ['Device: Nox A1 Recorder']}], 'interventions': [{'name': 'Continuous positive airway pressure (CPAP) therapy', 'type': 'DEVICE', 'description': "Standard, clinically used CPAP therapy. CPAP will be prescribed by the participants' clinician provider and not by the study investigators.", 'armGroupLabels': ['CPAP treatment of OSA']}, {'name': 'Nox A1 Recorder', 'type': 'DEVICE', 'description': 'Non-invasive, body-worn, sleep recording device for nocturnal polysomnography.', 'armGroupLabels': ['ILD screening for OSA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham & Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available no later than 3 years after last research subject is enrolled in the study.', 'ipdSharing': 'YES', 'description': 'Researchers will be required to submit a written request to the Study Principal Investigator (PI) describing the use of the specimens. The researcher must also document institutional review board (IRB) approval and sign a material transfer agreement. The Study PI will make all decisions about use of the specimens. No identifiable information will be released, only coded anonymized samples and non-identifiable clinical/demographic information. For genomic data generated from whole-exome sequencing, the genotype and relevant phenotype data for participants who consented to share data will be registered and shared through the database of Genotypes and Phenotypes (dbGaP), a controlled access database, once the sequencing data have been cleaned and quality control procedures are completed.', 'accessCriteria': 'Researchers will be required to submit a written request to the Study PI describing the use of the specimens. The researcher must also document IRB approval and sign a material transfer agreement. The Study PI will make all decisions about use of the specimens. No identifiable information will be released, only coded samples and non-identifiable clinical/demographic information.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Sanja Jelic', 'investigatorAffiliation': 'Columbia University'}}}}